US8162923B2 - Disposable infusion device with automatic unlocking mechanism - Google Patents

Abstract

A wearable infusion device delivers a liquid medicant to a patient. The infusion device comprises a base that contacts a patient's skin and a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin. The reservoir has an outlet through which the medicant flows. The infusion device further comprises a flexible conduit communicating with the outlet of the reservoir, a pump that causes the medicant to flow down the conduit, an actuator that performs a function related to the operation of the device, and an enable mechanism that enables the actuator in response to the filling of the reservoir with the liquid medicant.

Description

BACKGROUND OF THE INVENTION

Tight control over the delivery of insulin in both type I diabetes (usually juvenile onset) and type II diabetes (usually late adult onset), has been shown to improve the quality of life as well as the general health of these patients. Insulin delivery has been dominated by subcutaneous injections of both long acting insulin to cover the basal needs of the patient and by short acting insulin to compensate for meals and snacks. Recently, the development of electronic, external insulin infusion pumps has allowed the continuous infusion of fast acting insulin for the maintenance of the basal needs as well as the compensatory doses for meals and snacks. These infusion systems have shown to improve control of blood glucose levels, however, they suffer the drawbacks of size, cost, and complexity, which prevents many patients from accepting this technology over the standard subcutaneous injections. These pumps are electronically controlled and must be programmed to supply the desired amounts of basal and bolus insulin.

Hence, there is a need in the art for a simple, mechanically driven infusion device for both basal needs and boluses that is directly attached to the body and does not require any electronics to program the delivery rates. The insulin is preferably delivered through a small, thin-walled tubing (cannula) through the skin into the subcutaneous tissue similar to technologies in the prior art. The present invention, in its various embodiments, is directed to providing such a device.

SUMMARY OF THE INVENTION

The invention provides a wearable infusion device comprising a base that contacts a patient's skin, a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows, and a flexible conduit communicating with the outlet of the reservoir. The device further comprises a pump that causes the medicant to flow down the conduit, an actuator that performs a function related to the operation of the device, and an enable mechanism that enables the actuator in response to the filling of the reservoir with the liquid medicant.

The reservoir may be formed of flexible material and the enable mechanism may be responsive to the inflation of the reservoir upon being filled with the liquid medicant to enable the actuator. The reservoir may be an expandable structure and the enable mechanism may be responsive to expansion of the reservoir upon being filled with the liquid medicant to enable the actuator. The enable mechanism may comprise a follower that follows the expansion of the reservoir. The actuator may be displaced when performing the function related to the operation of the device, the device may further comprise a latch positioned to impede the displacement of the actuator, and the enable mechanism may reposition the latch when the reservoir is filled to permit the displacement of the actuator.

The enable mechanism may comprise a follower that follows the expansion of the reservoir and is coupled to the latch. The follower may comprise a bar extending across the reservoir.

The actuator actuates the pump to cause the medicant to flow down the conduit. The actuator may comprise at least one push button which, when depressed, causes the pump to cause the medicant to flow down the conduit. The device may further comprise a latch positioned to impede the displacement of the at least one push button, and the enable mechanism may reposition the latch when the reservoir is filled to permit the at least on push button to be depressed.

In another embodiment, a wearable infusion device comprises a base that contacts a patient's skin, a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows and being expanded upon being filled with the liquid medicant, and a flexible conduit communicating with the outlet of the reservoir. The device further comprises a pump that causes the medicant to flow down the conduit, an actuator that performs a function related to the operation of the device, and an enable mechanism that enables the actuator in response to expansion of the reservoir when the reservoir is filled with the liquid medicant.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:

FIG. 1 is a perspective view of an infusion device embodying the present invention;

FIG. 2 is a perspective view of the device ofFIG. 1 with its top cover removed and in a condition ready for having its reservoir filled with liquid medicant;

FIG. 3 is a perspective view of the infusion device ofFIG. 1 with its top cover removed after its reservoir has been filled with liquid medicant;

FIG. 4 is perspective view with portions cut away of the infusion device ofFIG. 1 illustrating the path of the liquid medicant within the device;

FIG. 5 is a top view of the device ofFIG. 1 with its reservoir removed to illustrate the manner in which the liquid medicant is caused to flow within the device;

FIG. 6 is a perspective view of the infusion device ofFIG. 1 with its reservoir removed illustrating further aspects of the pump thereof;

FIG. 7 is a perspective view of the infusion device ofFIG. 1 with portions cut away to illustrate a safety check valve in its opened position;

FIG. 8 is a perspective view similar toFIG. 7 illustrating the safety check valve closed;

FIG. 9 is a perspective view of a reservoir which may be used in the infusion device ofFIG. 1 in accordance with an alternate embodiment; and

FIG. 10 is a perspective view with portions cut away of the reservoir ofFIG. 9 illustrating further aspects thereof according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now toFIG. 1, it illustrates aninfusion device100 embodying the present invention. Theinfusion device100 may be useful, for example, in providing boluses of a liquid medicant, such as insulin, to be delivered beneath a patient's skin.

Thedevice100 generally includes a base110, atop cover120, and a cannula port130. The base110 prior to application to the patient's skin, carries afirst tab member112 and asecond tab member114. Thefirst tab member112, when removed, exposes alayer116 of antiseptic material such as alcohol which may be rubbed against the skin of the patient in the area in which thedevice100 is to be adhered. Once the antiseptic has been applied to the patient's skin, thesecond tab114 is removed exposing an adhesive layer on the base110 which is then used to adhere the device to the skin of the patient. Once the device is adhered to the skin of the patient, a cannula may be introduced into the device and beneath the skin of a patient through the cannula port130.

As may be seen inFIG. 2, thedevice100 further includes a pair ofactuator push buttons120 and areservoir140 arranged to contain the liquid medicant. As will be seen hereinafter, concurrent pressing of theactuator push buttons120 causes the liquid medicant within thereservoir140 to flow down aflexible conduit150 and eventually beneath the skin of a patient. Each of thepush buttons120 are spring loaded by an associatedspring122 and124 which return thepush buttons120 to their starting positions.

Thereservoir140 as shown inFIG. 2 does not yet contain the liquid medicant. Alatch mechanism160 precludes thepush buttons120 from being pressed when thereservoir140 is empty. To that end, it will be noted that afollower bar162 extends across thereservoir140 and terminates at alatch member164. Adog166 is coupled to thepush buttons120 and engages thelatch member164 to preclude theactuator buttons120 from being pushed when the reservoir is empty.

Referring now toFIG. 3, when the reservoir is filled as illustrated inFIG. 3, thefollower bar162 follows the expansion of thereservoir140. To that end, thereservoir140 is preferably formed of flexible material, such as plastic, and will expand upon being filled. Thefollower bar162 follows the filling of thereservoir140 to raise thelatch member164. When the reservoir is full, thelatch member164 is raised to such an extent that thedog166 may pass thereunder to permit thepush buttons120 to be pressed to cause pumping of the liquid medicant to the patient. Again, thesprings122 and124 assist in returning thepush buttons122 to a starting position.

Thereservoir140, as may be noted inFIG. 3, includes a plurality of raisedportions142 formed along its perimeter. This reservoir shape causes air pockets to be formed within the reservoir that traps air isolated from thereservoir outlet144. Accordingly, thedevice100 is intended to be worn with itsmajor axis102 horizontal. In such an orientation, air within thereservoir140 may be trapped in the air pockets, such asair pocket146.

Referring now toFIG. 4, it illustrates the fluid flow path of the liquid medicant upon being pumped responsive to the pressing of theactuator buttons120. The fluid flow path is shown in dashed lines inFIG. 4. As may be noted, the fluid flow fromreservoir140 begins at theoutlet144 along aflexible conduit148. The fluid medicant is propelled by a pump, such as a linearperistaltic pump170 to be described hereinafter. It first flows through avalve180 which may be provided to isolate thepump170 from thereservoir140 when thepump170 pumps the fluid medicant. Thevalve180, under some circumstances, is optional, as for example when a linear peristaltic pump of the type described herein is employed as will be fully described hereinafter.

The fluid continues to flow along theflexible conduit148 to eventually arrive at thecannula200. It is then delivered to the patient beneath the patient's skin.

FIGS. 5 and 6 show the peristaltic pump of thedevice100 in greater detail. Here it may be seen that the peristaltic pump comprises a pair ofpressure members172 and174. Thepressure members172 and174 are disposed on opposite sides of theflexible conduit148. The direction of fluid flow is indicated by thearrows149 in a direction away from the reservoir (not shown). Thepressure members172 and174 are spaced apart such that they become increasingly closer together in an upstream direction with respect to the fluid flow. Hence, when thepressure members172 and174 act upon theflexible conduit148, they will serve to first pinch the flexible conduit closed and then, upon exerting additional pressure, squeeze the conduit to force the liquid medicant in the downstream direction.

As previously mentioned, thevalve180 is optional. If the pump utilized is not a pump as illustrated herein that first closes off the conduit, thevalve180 may be coupled to theactuator buttons120 so that thevalve180 closes theconduit148 before pressure is exerted on theflexible conduit148 by the pump. To that end, thevalve180 includes a first valve member182 and a secondstationary valve member184. Valve member182 pivots aboutpivot point186 upon the pressing of theactuator buttons120 to pinch the flexible conduit closed against thestationary member184.

InFIG. 6, it may be more clearly seen that eachpressure member172 and174 is integrally formed with an associated one of theactuator buttons120. More specifically, each pressure member may be formed as one piece with itsactuator button120. Because thedevice100 is intended to be disposable, the actuator buttons and hence thepressure members172 and174 may be formed of plastic.

Once theactuator buttons120 are pressed and theperistaltic pump170 causes the liquid medicant to flow down theflexible conduit148, theactuator buttons120 are returned to their starting positions by theirrespective springs122 and124. At this point in time, theflexible conduit148 is charged with fluid to cause the fluid medicant to exit thecannula190 as illustrated inFIG. 4. To guard against back pressure within thecannula190 and flexible conduit which would otherwise lessen the amount of liquid medicant received by the patient, acheck valve190 is provided. Thecheck valve190 is downstream from thepump170 and performs at least two functions. Firstly, thecheck valve190 when closed precludes back flow of the medicant and assures that the medicant within the flexible conduit from the check valve to thecannula200 is eventually diffused into the patient. It also precludes unintended leaking of the liquid medicant into the patient in between actuations of thepush buttons120.

With particular reference toFIGS. 7 and 8, inFIG. 7, it will be noted that thevalve190 is formed by a closingmember192 which is coupled to anactuator push button120 at anattachment point194. When theactuator buttons120 are concurrently pressed, theclosure member192 slides to the position indicated inFIG. 7 to an opened position to permit fluid flow through theflexible conduit148. As may be seen inFIG. 8, when theactuator buttons120 are released, theclosure member192 is caused to move in a direction towards theflexible conduit148 and eventually pinches theflexible conduit148 closed between theclosure member192 and astationary wall196. Once thevalve190 is closed as shown inFIG. 8, liquid medicant will not be permitted to inadvertently drip from the reservoir, flow through the conduit, and be delivered to the patient.

Referring now toFIGS. 9 and 10, they show an alternative flexible reservoir which may be used in the infusion pump according to the invention. Theflexible reservoir240 is formed of flexible sheet material including asheet242 and a sheet244. Thesheet materials242 and244 are sealed along aperipheral seal line246. As may be clearly noted inFIGS. 9 and 10, thereservoir240 is shaped to form raisedportions248 on one side of the reservoir and raisedportions250 on the opposite side of the reservoir. The raisedportions248 and250 may be pointed regions having concave sidewalls. For example, pointedregions248 haveconcave sidewalls249 and pointedregions250 haveconcave sidewalls251.

When thereservoir240 is deployed in an infusion device, such asinfusion device100 ofFIG. 1, it may be disposed so that the raisedregions250 and248 are along a pane having a substantially vertical component. With thereservoir240 being disposed such that the raisedregions250 are above the raisedregions248, air pockets, such asair pocket253 will be formed within thereservoir240. Theair pocket253 is isolated from theoutlet256 to assure that no air will become entrapped in the liquid medicant being delivered to the patient.

Hence, as may be seen from the foregoing, the present invention provides a simple, mechanically driven infusion device that provides boluses of liquid medicant, such as insulin, and which may directly attached to the body of a patient. The device does not require any electronics to deliver or program the delivery of the medicant. The liquid medicant, such as insulin, may be delivered through a small cannula into the subcutaneous tissue of the patient as is common in the art.

While particular embodiments of the present invention have been shown and described, modifications may be made, and it is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention as defined by those claims.

Claims (18)

1. A wearable infusion device comprising:

a base adapted for contact to a patient's skin;

a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows;

a flexible conduit communicating with the outlet of the reservoir;

a pump that causes the medicant to flow down the conduit;

an actuator that performs a function related to the operation of the device; and

an enable mechanism that enables the actuator in response to the filling of the reservoir with the liquid medicant.

2. The device ofclaim 1, wherein the reservoir is formed of flexible material and wherein the enable mechanism is response to the inflation of the reservoir upon being filled with the liquid medicant to enable the actuator.

3. The device ofclaim 1, wherein the reservoir is an expandable structure and wherein the enable mechanism is responsive to expansion of the reservoir upon being filled with the liquid medicant to enable the actuator.

4. The device ofclaim 3, wherein the enable mechanism comprises a follower that follows the expansion of the reservoir.

5. The device ofclaim 1, wherein the actuator is displaced when performing the function related to the operation of the device, wherein the device further comprises a latch positioned to impede the displacement of the actuator, and wherein the enable mechanism repositions the latch when the reservoir is filled to permit the displacement of the actuator.

6. The device ofclaim 5, wherein the enable mechanism comprises a follower that follows the expansion of the reservoir and is coupled to the latch.

7. The device ofclaim 6, wherein the follower comprises a bar extending across the reservoir.

8. The device ofclaim 1, wherein the actuator actuates the pump to cause the medicant to flow down the conduit.

9. The device ofclaim 8, wherein the actuator comprises at least one push button which, when depressed, causes the pump to cause the medicant to flow down the conduit, wherein the device further comprises a latch positioned to impede the displacement of the at least one push button, and wherein the enable mechanism repositions the latch when the reservoir is filled to permit the at least one push button to be depressed.

10. The device ofclaim 9, wherein the enable mechanism comprises a follower that follows the expansion of the reservoir and is coupled to the latch.

11. The device ofclaim 10, wherein the follower comprises a bar extending across the reservoir.

12. A wearable infusion device comprising:

a base adapted for contact to a patient's skin;

a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows;

a flexible conduit communicating with the outlet of the reservoir;

a pump that causes the medicant to flow down the conduit;

an actuator, that actuates the pump to cause the medicant to flow down the conduit; and

an enable mechanism that enables the actuator in response to the filling of the reservoir with the liquid medicant, wherein the actuator comprises a pair of push buttons which when concurrently pushed, cause the pump to cause the medicant to flow down the conduit, wherein the device further comprises a latch positioned to impede the displacement of the push buttons to prevent the push buttons from being pushed, and wherein the enable mechanism repositions the latch when the reservoir is filled to enable the displacement of the push buttons and to permit the push buttons to be pushed.

13. The device ofclaim 12, wherein the enable mechanism comprises a follower that follows the expansion of the reservoir and is coupled to the latch.

14. The device ofclaim 13, wherein the follower comprises a bar extending across the reservoir.

15. A wearable infusion device comprising:

a base adapted for contact to a patient's skin;

a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows and being expanded upon being filled with the liquid medicant;

a flexible conduit communicating with the outlet of the reservoir;

a pump that causes the medicant to flow down the conduit;

an actuator that performs a function related to the operation of the device; and

an enable mechanism that enables the actuator in response to expansion of the reservoir when the reservoir is filled with the liquid medicant.

16. A wearable infusion device comprising:

a base adapted for contact to a patient's skin:

a reservoir arranged to be filled with a liquid medicant to be delivered beneath a patient's skin, the reservoir having an outlet through which the medicant flows and being expanded upon being filled with the liquid medicant;

a flexible conduit communicating with the outlet of the reservoir;

a pump that causes the medicant to flow down the conduit;

an actuator that performs a function related to the operation of the device; and

an enable mechanism that enables the actuator in response to expansion of the reservoir when the reservoir is filled with the liquid medicant wherein the actuator comprises a pair of push buttons which when concurrently pushed, cause the pump to cause the medicant to flow down the conduit, wherein the device further comprises a latch positioned to impede the displacement of the push buttons to prevent the push buttons from being pushed, and wherein the enable mechanism repositions the latch when the reservoir is filled to enable the displacement of the push buttons and to permit the push buttons to be pushed.

17. The device ofclaim 16, wherein the enable mechanism comprises a follower that follows the expansion of the reservoir and is coupled to the latch.

18. The device ofclaim 17, wherein the follower comprises a bar extending across the reservoir.

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